FDA clears AI chest X-ray triage software from Zebra Medical Vision

HealthPNX, an artificial intelligence alert for pneumothorax based on digital chest radiographs, received U.S. Food and Drug Administration (FDA) 510(k) clearance in May 2019, according to Zebra Medical Vision, Kibbutz Shefayim, Israel. The patent pending technology automatically detects findings suggestive of pneumothorax.

Zebra Medical Vision stated that this 510(k) clearance focuses on an artificial intelligence alert for urgent findings of pneumothorax. The company hopes that it can reduce turnaround time for radiologists and help increase their confidence in making a pneumothorax diagnosis. The company said that this diagnosis is one of the most difficult to interpret, with approximately 74,000 misdiagnoses or late diagnoses annually in the United States alone.

The company’s chest X-ray artificial intelligence network was trained using millions of images to identify over 40 common clinical findings. In addition to pneumothorax identification on chest X-rays, Zebra Medical’s AI1 Triage Solution has been developed to help identify intracranial hemorrhages on computed tomography (CT) scans, a product currently awaiting FDA clearance.